Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study (COV-NI)

COVID-19 is causing a serious viral pandemic in terms of health and social impact. To date, no treatment has yet demonstrated Strong efficacy in treating the infectious disease (COVID-19). Pulmonary administration of Interferon (IFN) type I is a therapeutic strategy with high potential,due to higher local concentrations and minimal adverse effects. Type I interferons (including IFN-α and IFN-β) are antiviral defence cytokines and also have the potential to negatively modulate IFN Type II and IL-6 dependent cytokine storm, the latter being induced in the late forms of COVID-19. In vitro, IFN-β were more effective on COVID-19 than IFN-α. In existing preliminary studies, only patients receiving IFN type I modulators have a decrease in viral carriage and a rapid reversal. The purpose of this project is to assess in hospitalized patients with oxygen for COVID 19, the clinical efficacy on oxygen requirements of the addition of inhaled Interferon type I compared to the control arm .

Study Overview

• Status: Completed
• Conditions: COVID-19; INTERFERON; NEBULIZATION
• Intervention / Treatment: Drug: inhaled type I interferon; Drug: WFI water nebulization

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jean-Philippe Lanoix, MD; Phone Number: (33)322668813; Email: lanoix.jean-philippe@chu-amiens.fr
• Study Contact Backup: Name: Aurélien Mary, MD; Phone Number: (33)22087140; Email: mary.aurelien@chu-amiens.fr

Study Locations

• France
  • Abbeville, France, 80142
    • CH d'Abbeville
  • Amiens, France, 80480
    • CHU Amiens
  • Compiegne, France, 60200
    • CH Compiègne-Noyon
  • Rang-du-Fliers, France, 62180
    • CH de l'Arrondissement de Montreuil-sur-mer
  • Saint-Quentin, France, 02100
    • Ch de Saint-Quentin
  • Tourcoing, France, 59208
    • CH de Tourcoing
  • Valenciennes, France, 59322
    • CH de Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old
• Patient with laboratory-confirmed SARS-CoV-2 infection as determined by PCR < 96 h (at initial diagnosis or persistent carriage <96 h)
• Hospitalized patient with COVID-19 requiring oxygen therapy

And targeting in phase B :

• Patients under oxygen therapy such as nasal cannula/mask or non-invasive ventilation with paO2/FiO2 > 200 mmHg.
• Patients hospitalized for less than 7 days.
• Patients with symptoms for less than 10 days or RT-PCR (<96h) with Cycle Treshold < 25.
• Social security coverage
• signed informed consent (by patient or their legally authorized representative)

Exclusion Criteria:

• Hypersensitivity to natural or recombinant interferon-ß
• Hypersensitivity to human albumin or mannitol
• Recent suicide attempt
• Decompensation of liver failure
• age < 18 years
• Pregnant or nursing.
• Patients managed on an outpatient basis (i.e. not initially hospitalized).
• Parenteral IFN treatment. In periode B, addition of new exclusion criteria
• Patients with kidney transplant
• Immunocompromised patients
• Patients with severe systemic disease constantly threatening their vital prognosis (ASA ≥ IV: e.g. severe ARF, advanced cancer pathology, recent myocardial IDM, severe valvular dysfunction, dependence on parenteral nutrition on central line, shock, sepsis, trauma, ...).
• Patients in septic shock.
• Patients with documented fungal infection.
• Patients on mechanical ventilation.
• Patients hospitalized for COVID-19 for more than 7 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhaled IFN arm; IFN (Interferon) pulmonary (Inhalation) + routine care (+/- antibiotics; +/- dexamethasone; + appropriate O2 support)	Drug: inhaled type I interferon; The interventional arm includes inhaled interferon (9.6 MUI x2/d for 48 hours, then 9.6 MUI x1/d for 8 to 16 days or discharge), in addition to standard care. In phase B, maximum treatment duration is 8 days.
Active Comparator: Control Arm: Aerosol (WFI water and routine care (+/- antibiotics;+/- dexamethasone; + appropriate O2 support).	Drug: WFI water nebulization; The interventional arm includes a WFI water nebulization comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen requirement score at day 0	oxygen requirement score at day 0	day 0
oxygen requirement score at day 15	oxygen requirement score at day 15	day 15
Variation oxygen requirement score between day 0 and day15	Variation oxygen requirement score between day 0 and day15	at day 15

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Jean-Philippe Lanoix, MD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; INTERFERON; NEBULIZATION
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Interferon Type I
• Other Study ID Numbers: PI2020_843_0041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No